NCT06512246

Brief Summary

This is a retrospective study, including 195 patients with gastrointestinal reconstruction, who treated with Endoscopic Retrograde Cholangiopancreatography (ERCP) at Beijing friendship hospital. The investigators assessed the outcomes of failure factors of ERCP and effectiveness of remedial measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 16, 2024

Last Update Submit

July 16, 2024

Conditions

Endoscopic Retrograde Cholangiopancreatography

Keywords

Endoscopic Retrograde CholangiopancreatographyGastrointestinal ReconstructionRemedial Measure

Outcome Measures

Primary Outcomes (1)

  • Rate of Reaching Duodenal Papilla

    successfully reaching duodenal papilla during the endoscopic procedure

    during the operation

Secondary Outcomes (4)

  • Successful Intubation Rate

    during the operation

  • Successful Endoscopic Treatment Rate

    during the operation

  • Effective Rate of Remedial Measures

    during the operation

  • ERCP-related complication rate

    during the operation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who diagnosed with gastrointestinal reconstruction underwent ERCP at Beijing Friendship Hospital.

You may qualify if:

  • Age ≥18 years old.
  • After gastrointestinal reconstruction (Billroth Ⅱ Anastomosis, Roux-en-Y Anastomosis).
  • Endoscopic retrograde cholangiopancreatography (ERCP) was performed for common bile duct stone with choledocholithiasis, pancreatic duct stenosis, or obstructive jaundice with endoscopic indication.

You may not qualify if:

  • After Billroth I Anastomosis.
  • Accompanied by serious cardiopulmonary disease or coagulation dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Study Officials

  • Fujing Lv

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 22, 2024

Study Start

April 1, 2024

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

July 22, 2024

Record last verified: 2024-07

Locations

CN(1)